UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trail against hyperlipidemia patients with high risks to investigate the effect on small dense LDL-C & IDL by using middle dose Rosuvastatin in Saitama
Title of the study (Brief title)	PIONEER Saitama
Region	Japan

Condition
Condition	Hyperlipidemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The lipid medical treatment by rosuvastatin to a high risk hyperlipidemia patient examines propriety aiming at disappearance of small dense LDL and IDL. The patients were estimated in 120 patients receiving coronary computed tomographic angiography (CCTA).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lipid profile (TC,TG,HDL-C, Friedewald LDL-C,small dense LDL,IDL),apo protein, apoE phenotype
Key secondary outcomes	Cr, BUN, Urinal analysis, GOT, GPT, CK, (following in the case of DM), fasting blood glucose, HbA1c. The coronary computed tomographic angiography (CCTA) was repeated and compared before and after treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rosuvastatin 5mg-20mg for 6 month
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)-3) 3 examine group 1)T2DM with 120 mg/dl or more than 120 mg/dl LDL-C 2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007 CategoryIII (Diabetes patients are excepted) with 120 mg/dl or more than 120 mg/dl LDL-C 3)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007 Secondary prevention with 100 mg/dl or more than 100 mg/dl LDL-C
Key exclusion criteria	A patient with the side-effects past in statin medication
Target sample size	200

Research contact person
Name of lead principal investigator	Ikuo Inoue
Organization	Saitama Medical University
Division name	Dept. of Endocrinology and Diabetology
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1875
Email	i1901018@saitama-med.ac.jp

Public contact
Name of contact person	Ikuo Inoue
Organization	Saitama Medical University
Division name	Dept. of Endocrinology and Diabetology
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1875
Homepage URL
Email	i1901018@saitama-med.ac.jp

Sponsor
Institute	Ikuo Inoue
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 07 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2014 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 10 Month 13 Day
Last modified on	2017 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007750